Clinical Quality Assurance Auditor - Remote US

Sarah Cannon Research Institute • Usa, TN

13h • Remote

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. Our Quality Assurance Auditor will be r esponsible for promoting the development and implementation of quality initiatives within SCRI through conduct of audits. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Requirements

• Bachelors Degree required
• 3+ years' work experience in a regulated clinical research environment required; Quality Assurance Auditing experience required
• Work experience with FDA regulations and GCP is required.
• Knowledge of 21 CFR Part 11 requirements and software validation principles

Nice To Haves

• Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred.

Responsibilities

• Plans and conducts GxP audits (e.g., internal, vendor, site)
• Develop a risk-based audit plan to determine the priorities of audit activities
• Conducts interviews with key staff to assess process completion, support inspection readiness and to communicate any potential observations or process improvement opportunities
• Communicates audit observations and process improvement opportunities through a written audit report distributed to the appropriate personnel
• Appropriately escalates any critically identified areas of deficiency in quality and reports those to organization leadership and other appropriate stakeholders
• Tracks, collects and reviews audit responses for timely and appropriate corrective action as follow-up to identified areas of non-compliance until audit closure
• Other duties as assigned

Benefits

• We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.
• As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees